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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:115190

COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.

Official recall number

Z-0762-2013

Evidence summary

Product code
MWA
Recall status
Terminated
Event initiated
November 28, 2012
Root cause
Component change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0762-2013